Introduction

Uses for Thrombin

Hemorrhage

Aids hemostasis at accessible sites of oozing blood and minor bleeding from capillaries and small venules.100 In various types of surgery, may be used in conjunction with an absorbable gelatin sponge.100

When used with an absorbable gelatin sponge, immerse sponge strips of the desired size in the solution and knead vigorously with moistened, gloved fingers to remove trapped air and facilitate saturation.100 Apply the saturated sponge to the bleeding area and hold in place with a cotton pledget or small gauze sponge until hemostasis occurs.100 Consult manufacturer's information for detailed instructions on use of absorbable gelatin sponge preparations.100

Reconstitution

To prepare a solution containing 1000 units/mL of thrombin (bovine), transfer entire contents of the supplied diluent vial (5 or 20 mL) to a vial containing 5000 or 20,000 units, respectively, of lyophilized thrombin via a syringe or transfer needle.100 Consult manufacturer's instructions for appropriate use of the transfer device.100

Use an appropriate volume of the 0.9% sodium chloride diluent to prepare other concentrations.100

Sensitivity Reactions

Hypersensitivity Reactions

Antibody Formation

Can stimulate antibody formation against bovine thrombin and/or bovine factor V (a potential contaminant in some bovine thrombin preparations).100103104105106109110111112 Such antibodies may cross-react with human factor V, potentially resulting in a factor V deficiency and hemorrhagic complications; paradoxical thrombosis also has occurred.100103105106107109111112 (See Effects on Hemostasis under Cautions.) Antibodies may develop as early as 8 days after use and may persist for months to years following initial exposure.103105106111 Not known whether highly purified preparations (i.e., containing no detectable levels of factor Va) are associated with reduced risk of immunogenicity.100109

Patients with evidence of anti-bovine thrombin antibodies should not be reexposed to the drug; increased likelihood of antibody formation with repeated application.100103104105106107109111

Concomitant Absorbable Gelatin Sponge

Specific Populations

Pregnancy

Pediatric Use

Stability

Storage

Topical

Powder

2–25°C.100 May refrigerate reconstituted solution at 2–8°C for up to 24 hours or store at room temperature for up to 8 hours.100

Actions

Causes clotting of whole blood or plasma without the addition of other substances.100b Affects hemostasis principally by converting fibrinogen to fibrin; several other mechanisms (e.g., stimulation of platelet release reaction, aggregation of platelets) may be involved.100109b

Rate of blood clotting depends on concentration of thrombin and fibrinogen.100b

Does not clot blood when clotting defect is the rare absence of fibrinogen.100